Study to Image the Esophagus Using the OFDI Capsule



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:16 - Any
Updated:12/7/2018
Start Date:February 2012
End Date:July 2016

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Pilot Study for Imaging of the Esophagus Using an OFDI Capsule

The main purpose of this research is to test the feasibility and tolerability of the tethered
capsule Optical Frequency Domain Imaging (OFDI) screening probe in healthy subjects, patients
with Barrett's Esophagus and Eosinophilic Esophagitis.

A total of 54 subjects comprising of healthy volunteers, patients with Eosinophilic
Esophagitis (EoE) or Barrett's Esophagus will be asked to swallow the OFDI capsule while
being unsedated. The capsule is attached to a tether that allows the capsule operator to
navigate the capsule as it progresses down the esophagus using natural propulsion called
peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is
done.

As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross-
sectional images of the esophagus are acquired.

Inclusion Criteria:

- A previous diagnosis of Barrett's Esophagus

- OR a previous diagnosis of EoE

- OR a previous diagnosis of Gastroesophageal reflux disease (GERD)

- Subject must be 18 years or older in case of Barrett's and GERD, and over the age of
16 years for EoE

- Subject must be able to give informed consent

Exclusion Criteria:

- Subjects with known esophageal strictures, intestinal strictures or dysphagia

- OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-4422
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Boston, MA
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